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Study of Disrupted Sleep in Somali Americans

Sponsor
Mayo Clinic (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05411029
Collaborator
National Institutes of Health (NIH) (NIH)
240
Enrollment
1
Location
83
Anticipated Duration (Months)
2.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The aims of this study are to determine the types and severity of previously undiagnosed sleep deficiencies in otherwise healthy Somali Americans, apply a research framework to define psychosocial, behavioral, environmental, and biological mechanisms mediating sleep deficiencies in Somali Americans, and examine the relationship between sleep deficiencies and increased blood pressure in Somali Americans.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: 24 hour blood pressure (BP) monitoring
  • Diagnostic Test: Polysomnography

Study Design

Study Type:
Observational
Anticipated Enrollment :
240 participants
Observational Model:
Ecologic or Community
Time Perspective:
Prospective
Official Title:
Disrupted Sleep in Somali Americans - Implications for Hypertension Risk
Anticipated Study Start Date :
Aug 1, 2022
Anticipated Primary Completion Date :
Jul 1, 2029
Anticipated Study Completion Date :
Jul 1, 2029

Arms and Interventions

Arm Intervention/Treatment
Healthy Somali Americans

Somali Americans with no known history of hypertension, diabetes, or sleep disorders will have a 24 hour blood pressure monitoring and polysomnography.

Diagnostic Test: 24 hour blood pressure (BP) monitoring
24-hour ambulatory BP measuring device and blood pressures will be measured every 20 minutes to half hour

Diagnostic Test: Polysomnography
Measurements will include electroencephalogram, electromyogram, electrooculogram, electrocardiogram, breathing patterns of chest and abdomen, nasal and oral airflow and oxygen saturation. Sleep stages and apneas will be scored in accordance with validated American Academy of Sleep Medicine standards.
Other Names:
  • Sleep Study

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Undiagnosed sleep deficiency-short sleep [1 night sleep study, approximately 8-9 hours]

      Number of subjects to have short sleep (<6 hours) as measured by the sleep study

    2. Undiagnosed sleep deficiency-insomnia [1 night sleep study, approximately 8-9 hours]

      Number of subjects to have insomnia as measured by the sleep study

    3. Undiagnosed sleep deficiency-obstructive sleep apnea (OSA) [1 night sleep study, approximately 8-9 hours]

      Number of subjects to have OSA as measured by the sleep study

    4. Disrupted sleep [1 night sleep study, approximately 8-9 hours]

      Number of subjects to have disrupted sleep as measured by the sleep study

    5. Blood pressure (BP) during wakefulness [Day 2]

      Average BP as measured by 24 hour BP monitoring, reported in mmHg

    6. Blood pressure (BP) during sleep [Day 2]

      Average BP as measured by 24 hour BP monitoring, reported in mmHg

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • Subjects diagnosed with no known history of hypertension, diabetes, or sleep disorders.

    • Self-identify as Somali.

    • Adult males and females who are older than 18 years of age.

    Exclusion Criteria:

    • Anyone under 18 years or over 70 years.

    • Positive pregnancy.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Mayo Clinic in Rochester Rochester Minnesota United States 55905

    Sponsors and Collaborators

    • Mayo Clinic
    • National Institutes of Health (NIH)

    Investigators

    • Principal Investigator: Virend Somers, MD, Mayo Clinic

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Virend Somers, MD, PhD, Principal Investigator, Mayo Clinic
    ClinicalTrials.gov Identifier:
    NCT05411029
    Other Study ID Numbers:
    • 22-004192
    First Posted:
    Jun 8, 2022
    Last Update Posted:
    Jun 8, 2022
    Last Verified:
    Jun 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Sleep Wake Disorders
    Hypertension

    Study Results

    No Results Posted as of Jun 8, 2022